The invention relates to an apparatus and technique for treatment and fluoroscopic mapping of treated tissue by injection of radiographic contrast agent into the tissue and contemporaneous treatment of the same tissue to provide a radiographic visual map of treated locations. The invention also relates to use of such apparatus and technique to promote revascularization of heart muscle/tissue.
Recent research and investigation suggests that part of the process of healing wounds in human tissue is dependent on blood vessel growth, which is believed to be in turn dependent on release of angiogenesis or blood vessel growth factors by the ischemic (or injured) tissue. It has been suggested at a recent conference on angiogenesis and direct myocardial revascularization that any method, i.e., laser, radio frequency electromagnetic signals, or other technique that results in myocardial tissue ischemia (or injury) may result in release of angiogenesis growth factors and development of blood vessel growth and blood flow to the ischemhc/injured area. (As used herein, the term "ischemic" is intended to refer to reversible tissue damage and the term "injury" is intended to refer to irreversible tissue damage.)
While there are publications of references that disclose dyeing tissue of the heart during direct open heart surgery to mark lased or otherwise treated sites thereof, and although there are prior references disclosing introduction of radiographic contrast agent into various organs such as the chambers of the heart or coronary arteries for the purpose of radiographic imaging of the contractions of the heart, the prior art does not disclose use of needles or other means installed on distal ends of catheters to inject radiographic contrast agents into heart muscle or other tissue. In fact, in prior practice injection of radiographic contrast agent directly into tissue is deliberately avoided. However, angiogenesis factors alone have been injected into heart muscle tissue.
My U.S. Pat. No.4,976,710 entitled "WORKING WELL BALLOON METHOD", issued Dec. 11, 1990, incorporated herein by reference, discloses a working well balloon catheter and method for visualizing and performing procedures on the inner myocardial wall.
There is an unmet need for an improved apparatus and technique for performing medical procedures on tissue within the body, especially within the heart, and repetitively radiographically marking contemporaneously treated sites so the physician can avoid multiple treatments of the same areas, to avoid complications such as perforation of the heart, to facilitate completion of a procedure to decrease radiation exposure of the patients, and to reduce overall costs by providing a more efficient method of treatment. In contrast, conventional radiography does not provide a way to determine if an internal area already has been subjected to contemporaneous treatment.